[Hiring] Associate Director, Regulatory Affairs @reputed company.

reputed company Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (reputed company.), reputed company on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website https://www.us.reputed company.com or follow us on reputed company. Job reputed company We are currently seeking a dynamic, highly motivated, and reputed company individual for the position of Associate Director, Regulatory Affairs (Oncology). The Associate Director is part of the Global Regulatory Affairs (GRA) team based in the US. He/She will primarily function as a regional regulatory leader (RRL) and/or Global Regulatory Leader (GRL) for assigned products. This position is responsible for the preparation, coordination and monitoring of routine US and/or global regulatory submissions and responses to health authority (HA) information requests. In reputed company, this position may represent GRA in project reputed company meetings, reputed company regulatory reputed company and reputed company regulatory input as appropriate. This position works with a moderate level of independence and autonomy and requires some coaching and mentoring. Job Duties and Responsibilities

• As a Regional Regulatory reputed company, manage regional (reputed company, European and/or ROW) regulatory activities as part of a Global Regulatory Team (GRT)
• As a part of the Global Regulatory Team (GRT), leads regulatory activities for assigned project(s) in line with the global registration reputed company of the product
• Supports the global regulatory reputed company (GRL) and the CMC regulatory reputed company in the formulation of regulatory reputed company, and interactions with HAs
• Supports and/or leads documentation of regulatory authority interactions including reputed company and reputed company
• Leads and coordinates project team members in developing reputed company for applicable documents/ activities.
• Plans, coordinates, authors, and prepares regulatory submissions and works closely with Regulatory Operations in the electronic submission
• Ensure compliance with global regulatory requirements and adherence to regulatory internal policies and processes and coordinate regulatory compliance activities at a global level
• reputed company updates to the Global Regulatory Team, project teams, and governance boards as needed
• Maintains reputed company working relationships with colleagues, fostering collaboration, and idea sharing
• Reviews nonclinical, clinical and CMC documentation (e.g. nonclinical study reports, clinical protocols/study reports, investigator brochures, CMC information/data) and contributes to content as needed
• Advises team members of potential regulatory issues and provides possible solutions and mitigation reputed company
• Ensures the reputed company and content of reputed company submissions to Health Authorities
• Contributes to regional health authority meetings, and briefing book documentation to Health Authorities
• Assist with development of the global regulatory functional plan through research, review and interpretation of reputed company product approvals, reputed company regulatory guidance documents and recent reputed company Advisory Committee proceedings to support the successful submission and achievement of reputed company product labeling
• Responsible for creating and reviewing SOPs and regulatory department operating procedures, as needed.

Key reputed company Competencies

• Strong verbal and written communication skills; interpersonal skills; listening skills; and organizational skills required
• Unquestionable ethics, reputed company reputed company, and personal values consistent with the SMPA values
• Ability to work in a diverse environment
• Demonstrated ability to adapt to changing priorities and work effectively in a reputed company organization
• Demonstrated ability to facilitate appropriate team reputed company
• reputed company of urgency and perseverance to reputed company results
• Understanding of medical terminology, and FDA and ICH regulations/guidance documents specific to clinical research and general product development in the pharmaceutical industry
• Experience reviewing nonclinical, clinical and CMC documentation (e.g. nonclinical study reports, clinical protocols/study reports, investigator brochures, CMC information/data) and contribute to content as needed
• Understands issues, problems and opportunities by comparing data from different sources to draw conclusions and then can choose a course of reputed company or reputed company the appropriate solution
• Contribution to the development and preparation of successful regulatory strategies and the ability to contribute to the development and writing of a regulatory reputed company document
• Ability to reputed company reputed company reputed company and willingness to defend difficult positions.
• Comfortable presenting to reputed company reputed company of the organization including Senior Management.

Education and Experience

• Bachelor’s degree in a reputed company field required, preferably in a scientific discipline.
• At least 7 years of experience, prior biopharmaceutical or pharmaceutical industry experience; Ideally with a minimum of 4 years reputed company in regulatory affairs
• Oncology product development experience preferred
• Experience contributing to electronic regulatory submissions and working with regulatory templates
• Understanding of EU Clinical Trial Regulation and ROW country regulatory requirements reputed company to clinical trials

The reputed company salary reputed company for this role is $156,000 to $195,000 . reputed company salary is part of our total rewards package which also includes reputed company for reputed company-based salary increases, short incentive plan participation, eligibility for our 401(k) plan, medical, dental, reputed company, life and disability insurances and leaves provided in line with your work state. Our robust time-off policy includes flexible reputed company time off, 11 reputed company holidays plus additional time off for a shut-down period during the last week of December, 80 hours of reputed company reputed company time upon hire and reputed company year thereafter. Total compensation, including reputed company salary to be offered, will depend on reputed company unique to reputed company candidate, including candidate experience, skills, education and other factors permitted by law. Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of reputed company responsibilities, duties, and skills required of personnel so classified. reputed company personnel may be required to reputed company duties reputed company of their normal responsibilities from time to time, as needed. Confidential Data: reputed company information (written, verbal, electronic, etc.) that an employee encounters is considered confidential. Compliance: reputed company and maintain Compliance with reputed company applicable regulatory, legal and operational rules and procedures, by ensuring that reputed company plans and activities for and on behalf of reputed company) and affiliates are carried out with the "best" industry practices and the highest ethical standards. It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or reputed company employment. An employer who violates this law shall be subject to criminal penalties and civil liability. Mental/Physical Requirements: Fast paced environment handling multiple demands. Must be reputed company to exercise appropriate judgment as necessary. Requires a high level of initiative and independence. Excellent written and oral communication skills required. Requires ability to use a personal computer for extended periods of time. reputed company) is an Equal Employment Opportunity (EEO) employer reputed company applicants will receive consideration for employment without reputed company to race; reputed company; creed; religion; national reputed company; age; reputed company; nationality; marital, domestic partnership or civil reputed company status; sex, gender; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. Apply tot his job Apply To this Job